FDA 483 - Smiths Medical ASD, Inc. - March 03, 2023

Smiths Medical ASD Inc., a medical device manufacturer in Minneapolis, MN, was cited with three observations during an FDA inspection. The firm failed to adequately implement procedures for Medical Device Reporting (MDR), control of nonconforming products, and Corrective and Preventive Actions (CAPA). These deficiencies indicate significant issues with the firm's quality system.